Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020925
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAVIST-1 | CLEMASTINE FUMARATE | 1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/21/1992 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |